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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011556
Receipt No. R000013520
Scientific Title Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Date of disclosure of the study information 2013/08/26
Last modified on 2015/05/14

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Basic information
Public title Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Acronym Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Scientific Title Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Scientific Title:Acronym Comparative Study of Early Efficacy of Once-Daily Dosing between Silodosin 4mg and Tamsulosin 0.2mg for Voiding Symptoms Associated with Benign Prostatic Hyperplasia
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is intended for elderly patients aged 65 years or older with moderate or severe voiding symptoms associated with benign prostatic hyperplasia. The subjects will be randomized to receive silodosin 4 mg or tamsulosin 0.2 mg once daily after breakfast for 4 weeks. Efficacy in early stages after administration and safety will be compared between the 2 groups.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IPSS voiding symptom score
Key secondary outcomes (1) Efficacy;
IPSS total score and subscores
QOL score
OABSS
Urodynamic parameters
(2) Safety;
Blood pressure
Adverse events and adverse drug reactions

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Silodosin 4 mg, once daily after breakfast
Interventions/Control_2 Tamsulosin 0.2 mg, once daily after breakfast
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria (1)Subject must have urinary symptoms associated with benign prostatic hyperplasia.
(2)Subject must give written informed consent.
(3)Subject must satisfy the following conditions during screening conducted at the start of the treatment period (Day 0):
* the total IPSS voiding symptom score is 8 or more,
* the QOL score is 2 or more,
* prostate volume is 20 mL or more,
* maximum urinary flow rate (Qmax) is 15 mL/sec or less, and
* residual urine volume is less than 100 mL.
(4)Subject must not use prohibited concomitant drugs except at least 2 weeks before the start of the treatment period (Day 0), or the subject must be able to undergo a drug washout for at least 2 weeks before the start of the treatment period.
(5)Subject must be an outpatient who can fill in the questionnaire.
(6)Subject must be 65 years or older at the time of signing the informed consent.
Key exclusion criteria (1)Subject is contraindicated to silodosin or tamsulosin according to the respective package insert.
(2)Subject has received prostatic resection.
(3)Subject has received radiotherapy to the pelvic region.
(4)Subject has received hyperthermia or thermotherapy for prostatic hypertrophy.
(5)Subject has or is suspected to have prostate cancer.
(6)Subject has neurogenic overactive bladder, bladder neck contracture, urethral stricture, bladder stones, large bladder diverticulum, active urinary tract infection requiring treatment, or other complications that may affect urination.
(7)Subject performs self-catheterization.
(8)Subject has taken any of the following drugs within 12 months before the start of treatment period (Day 0):
* silodosin or tamsulosin,
* 5alpha-reductase inhibitors, or
* antiandrogen drugs.
(9)Subject has clinically important cardiovascular disturbances.
(10)Subject has clinically important hepatorenal diseases.
(11)Subject has a history of severe drug hypersensitivity.
(12)Subject is scheduled to have cataract surgery in the study period.
(13)Subject has or is suspected to have a complication of dementia.
(14)Subject is considered inappropriate for participating in the study by the subinvestigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Matsushita
Organization Matsushita Urology Clinic
Division name Director
Zip code
Address 459 Minamitada Usui-no-tsubo, Kaibara-cho, Tanba-shi, Hyogo
TEL 0795-73-0266
Email kzkk77731@leto.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Orie Watanabe
Organization Sogo Rinsho M&eacute;d&eacute;fi Co., Ltd
Division name Business Promotion Department
Zip code
Address 3-2-7 Nishi-shinjuku, Shinjuku-ku, Tokyo
TEL 03-6901-6079
Homepage URL
Email watanabe.orie@sogo-medefi.jp

Sponsor
Institute Matsushita Urology Clinic
Institute
Department

Funding Source
Organization KISSEI PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 26 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 22 Day
Last modified on
2015 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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